Wearable Active-Compression Therapy and Treatment

ABSTRACT

Apparatus and associated methods relate to a wearable compression therapy system for ambulatory therapy, the system including a wearable garment having one or more inflatable chambers, and a pneumatic engine locally coupled to the garment to provide control and inflation of the one or more inflatable chambers. In an illustrative embodiment, the pneumatic engine may control a pump and one or more valves to inflate the inflatable chambers. The valves and pump may be coordinated according to a pre-programmed profile. In some embodiments, the pneumatic engine may have a wireless interface configured to receive control signals from a remote mobile device untethered from the garment. The pneumatic engine may send to the remote mobile device signals indicative of sensed conditions of the compression therapy system. In some embodiments, the pneumatic engine may include a power source that advantageously permits the user to be untethered from a source of power.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/654,459 (Attorney Docket No. 114-05-1), entitled “WearableActive-Compression Therapy And Treatment System”, filed by Ryan Douglason Oct. 16, 2019, which application is a continuation of U.S. patentapplication Ser. No. 14/965,668 (Attorney Docket No. 114-05), entitled“Wearable Active-Compression Therapy And Treatment System”, filed byRyan Douglas on Dec. 10, 2015, which claims the benefit of U.S.Provisional Application Ser. No. 62/090,088, titled “WearableActive-Compression Therapy and Treatment System,” filed by Douglas, onDec. 10, 2014. This application incorporates herein the entirety of theforegoing documents by reference.

TECHNICAL FIELD

Various embodiments relate generally to wearable pneumatic compressiontherapy devices.

BACKGROUND

Compression therapy and/or massage therapy is used in treating variousdiseases and injuries. Compression therapy is a non-invasive mechanicalmethod used for a variety of therapies and treatments. Compressiontherapy may be used to aid in the healing of wounds. Injuries thatrequire portions of the body to be stabilized during recovery may usecompression therapy to aid in such stabilization. Compression therapymay be used in the treatment of venous leg ulcers. Various forms ofcompression therapy may be used to treat Edema. Deep vein thrombosis mayinvolve compression therapy in a treatment regime.

Compression therapy may be performed using active methods and/or passivemethods. Passive methods may include the use of compression bandages andcompression garments. Compression garments may be garments that have anelastic that provides compression to a location on the body.Tight-fitting leggings may be worn to provide compression of the legs,for example. Tight-fitting sleeves may be worn to provide compression ofan arm, for example. Active methods may include the use of pneumaticpumps and inflatable chambers configured to provide pressure to parts ofthe human body.

SUMMARY

Apparatus and associated methods relate to a wearable compressiontherapy system for ambulatory therapy, the system including a wearablegarment having one or more inflatable chambers, and a pneumatic enginelocally coupled to the garment to provide control and inflation of theone or more inflatable chambers. In an illustrative embodiment, thepneumatic engine may control a pump and one or more valves to inflatethe inflatable chambers. The valves and pump may be coordinatedaccording to a pre-programmed profile. In some embodiments, thepneumatic engine may have a wireless interface configured to receivecontrol signals from a remote mobile device untethered from the garment.The pneumatic engine may send to the remote mobile device signalsindicative of sensed conditions of the compression therapy system. Insome embodiments, the pneumatic engine may include a power source thatadvantageously permits the user to be untethered from a source of power.

Various embodiments may achieve one or more advantages. For example, thelocal coupling of the pneumatic engine to the wearable garment mayreduce or eliminate tubing. Reduced or eliminated tubing may preventaccidents due to the tubing being caught on an object. Providing controlvia a remote mobile device may reduce the form factor of the garment andpneumatic engine. A reduced form factor may promote user mobility and/orflexibility during compression therapy. For example, a user may work ata desk while simultaneously undergoing compression therapy of an arm ora leg. In some embodiments, the controller may be integrated into thewearable garment such that the device can provide therapy whileuntethered to a physical location, and/or while operating autonomouslywithout connection to any external peripheral devices (e.g., no mobiledevices needed for control). In some embodiments, the user may beambulatory such that the user is able to walk about while undergoingcompression therapy, which may dramatically reduce recovery times andimprove patient outcomes, for example, relative to therapy whilemechanically tethered to another device.

The remote mobile device may include sophisticated programming options.For example, a therapy schedule may adapt to ambient temperature and/orbarometric pressure, for example. In some embodiments, a therapyschedule may be adapted in response to a calculated health metric. In anexemplary embodiment, a therapy schedule may be reduced in response toan improving calculated health metric. Such adaptive therapy schedulesmay minimize inconvenience to a user who is undergoing therapy.Minimizing the therapy time may promote positive mental health.

In some embodiments, the inflatable chambers may be incorporated in ashirt or pants, for example. The user may don the shirt or pants havingthe inflatable chambers as otherwise normal clothing. And when it istime for the user's daily therapy, a system controller may automaticallyprovide airflow to the inflatable chambers, for example. Such automaticcontrol may help a user to comply with a doctor's prescribed therapyregime. Regular compliance of a therapy regime may improve the positivehealth benefits of such a therapy regime.

The details of various embodiments are set forth in the accompanyingdrawings and the description below. Other features and advantages willbe apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a scenario in which a user is wearing an exemplary activecompression therapy system.

FIG. 2 depicts a block diagram of an exemplary untethered wearableactive compression therapy system.

FIG. 3 depicts a flowchart of an exemplary control method of anexemplary compression therapy routine.

FIG. 4 depicts a flowchart of an exemplary method of adaptivelyselecting a therapy session associated with a patient's tissuecondition.

FIG. 5 depicts a schematic view of an exemplary detachable controllersystem for a wearable inflatable compression therapy garment.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

To aid understanding, this document is organized as follows. First, anexemplary untethered active compression therapy device is brieflyintroduced with reference to FIGS. 1. Second, with reference to FIG. 2,exemplary system components of a wearable compression therapy system aredetailed. Then, with reference to FIG. 3, an exemplary method ofautomatically performing a compression therapy schedule will bedescribed. Finally, with reference to FIG. 4, an exemplary method ofusing measured therapy metrics to adjust a therapy schedule will bedescribed.

FIG. 1 depicts a scenario in which a user is wearing an exemplary activecompression therapy system. In the FIG. 1 depiction, a user 100 of anuntethered compression therapy system 105 is walking about. Thecompression therapy system 105 includes an inflatable garment 110, awearable controller 115, and a mobile device 120 running a pneumatictherapy application (“APP”). The mobile device 120 and the wearablecontroller 115 may be in wireless communication with one another, forexample. The wearable controller 115, may include a pneumatic pump forgenerating air pressure. The wearable controller 115 may include one ormore valves to control airflow to and/or from the inflatable garment110. One or more sensors may be included in inflatable garment 110and/or the wearable controller 115 to monitor one or more parameters ofthe untethered compression therapy system 105. For example, a pressuresensor in the wearable controller 115 may be indicative of the pressureapplied to the user's arm by the inflatable garment 110. The wearablecontroller 115 may compare a signal of the pressure sensor to apredetermined threshold. The wearable controller 115 may control thepneumatic pump and/or the valves in response to the comparison, forexample. The wearable controller 115 may advantageously maintain apressure in the inflatable garment 110 that is substantially equal to atherapy pressure that is predetermined by a therapy routine, whilepermitting the user 100 to remain mobile and untethered to a controldevice or a power source.

The APP running on the mobile device 120 may be configured tocommunicate with a remote data warehouse 125. The APP may log dataassociated with a therapy session being conducted on the user 100, forexample. The APP may send the logged data to the remote data warehouse125 where other users' data may be also received. The remote datawarehouse 125 may communicate the user's data to a physician 130 underwhom the user 100 is being treated. The physician 130 may alter thetherapy schedule of the user 100 in response to the communicated user'sdata, for example. The altered therapy schedule may then be sent to themobile device 120, for example. The next day's therapy session maybegin, for example, with the mobile device sending signals correspondingto the revised therapy session to the wearable controller 115 so thewearable controller may send signals to the pneumatic pump and airvalves that may comply with the revised therapy session.

For example, if the user's data is indicative of the user 100 notimproving as much and/or as quickly as the physician expected, thephysician 130 may intensify the therapy regime associated with the user100. Conversely, if the user's data is indicative of the user 100showing significant improvement, the physician 130 may reduce theintensity of the therapy regime associated with the user 100. In someembodiments, the remote data warehouse 125 may provide data analysis onthe data from many users. These data may be used to determine therapysystem parameters that are likely to provide successful therapy, and/ortherapy system parameters that are unlikely to provide successfultherapy.

A user's data may be analyzed to evaluate the therapy system 105 itself.For example, if the therapy system 105 has a pneumatic pump that isdegrading, the data warehouse may discover this condition when comparingthe user's current data with the user's past data. The data warehousemay notify the user that the therapy system 105 needs maintenance orreplacement, for example.

FIG. 2 depicts a block diagram of an exemplary untethered wearableactive compression therapy system. In FIG. 2, a block diagram 200 of anexemplary untethered wearable active compression therapy system includesa compression garment 205, a compression garment controller 210 and amobile device 215. The compression garment 205 includes a plurality of Npneumatic chambers 220. The compression garment 205 also includes apressure sensor 225 for each of the N pneumatic chambers 220. In someembodiments the compression garment controller may include a pressuresensor for one or more of the pneumatic chambers 220, for example.

The compression garment controller 210 is configured to provide airflowto and from the N pneumatic chambers 220 of the compression garment 205.The compression garment controller 210 is configured to receive signalsfrom the N pressure sensors 225 of the compression garment 205. Thecompression garment controller is configured to wirelessly communicatewith the mobile device 215, upon which an APP 230 is running. In someembodiments, the compression garment controller 210 may be configured toperform a compression therapy session independently of the mobile device215. In some embodiments, the compression garment controller 210 may beconfigured in such a way as to require regular communications with themobile device 215 during a compression therapy session.

The depicted compression garment controller 210 has a microprocessor 235which executes a program stored in program memory 240. Themicroprocessor 235 may use data memory 240 for storing data being usedduring a compression therapy session, for example. The microprocessor235 may be in electrical communication with a wireless input/outputmodule 250. In some embodiments a wireless communications link may beestablished between a wireless input/output module 255 of the mobiledevice 215 and the wireless input/output module 250 of the compressiongarment controller 210. For example, the mobile device 215 and thecompression garment controller may be paired and use a Bluetoothwireless communications standard. In some embodiments, variouscommunications protocols may be used. For example, Wi-Fi or near fieldcommunications protocols may be used. In an exemplary embodiment,cellphone communications standards may be used.

The depicted compression garment controller 210 includes a sensorinterface module 260, which is configured to receive signals from thepressure sensors 225 of the compression garment 205. The compressiongarment controller 210 includes a pump controller 265 and a pneumaticpump 270. The compression garment controller 210 includes one or morevalves 275 which receive air from the pump 270 and supply air to the oneor more pneumatic chambers 220 of the compression garment 205. In someembodiments, the valves 275 may be located in the compression garment205. The valves 275 may be controlled by the microprocessor 235 via oneor more valve controllers 280. The valve controllers 280 may be locatedin the compression garment 205, in some embodiments.

The mobile device has a microprocessor 285 that executes theinstructions associated with the APP 230. The APP 230 may haveinstructions that correspond to a Graphical User Interface (“GUI”). Themicroprocessor 285 may send and/or receive signals to/from a userinterface 290 that correspond to the GUI. For example, the APP 230 mayhave instructions that sound an alarm when it is time for a therapyroutine to be executed. The processor 285 may send signals that presenta graphical button on a display screen. When the button is pressed bythe user, a signal is generated and received by the microprocessor 285,the signal indicative of the user's initiation of the scheduled therapyroutine. The microprocessor 285 may send one or more signalscorresponding to such an event to the compression garment controller inresponse to receiving the begin therapy signal. The signals sent by themicroprocessor 285 may include a predetermined pressure for one or morepneumatic chambers for example.

In some implementations, the compression garment controller may beattached to the garment and provides a wired or wireless communicationinterface for receiving command instructions, and executing thosecommand instructions by operatively controlling one or more pumps orvalves that are embedded in the compression garment 205. In addition,some embodiments may further provide for the status information aboutthe garment controller 210 and its controlled devices (e.g., pump 270,valves (1:N) 275) to be communicated via the same interface. Such statusinformation may also include information about an energy storage element(e.g., battery pack) integrated with the garment for supplying power tooperate the garment 205 during therapy and/or while communicating with,for example, the mobile device 215. In some implementations, theinterface for receiving command instructions and communicating statusinformation may include an electrical connector for making galvanicconnection between an external control device and the compressiongarment controller 210. If wired, the communication interface may alsoreceive electrical power (e.g., 5, 12 or 24 DC), which may be processedby the garment for operating power and/or to recharge the energy storageelement.

In some embodiments, the communication interface may also communicatemeasurement data collected by sampling using any of the sensors that maybe operatively coupled to the compression garment controller 210. Someof the sensors that are operatively coupled to, and monitored by, thecompression garment controller 210 may include optionally includedsensors, such as temperature, SpO2, and/or pulse measurement sensorsthat can be, for example, releasably plugged into one or more externalports of the compression garment controller 210. Such external ports mayadvantageously provide customizable expansion of the array of sensorsthat are monitored by the compression garment controller 210.

In some embodiments, the compression garment controller 210 may beconfigured as a packaged module that releasably couples to thecompression garment 205. In such embodiments, some elements of thecompression garment controller 210 may be housed in the packaged module,and then operatively coupled to operate the compression garment uponbeing plugged into an electrical connector. In an example, the packagedmodule may be received in a pocket formed on the garment, for example.The packaged module may make operative connection to the electricalconnector when the module is inserted fully into the pocket so that thepackaged module seats on the electrical connector. Upon connection tothe electrical connector attached to the garment, the controller modulemay provide functional control for operating the compression garment 205to deliver a predetermined treatment profile to the patient. Thecompression garment controller 210 may operate in a stand-alone capacityto deliver compression therapy according to a predetermined profilestored in a memory, such as the memory devices 240, 245.

Some embodiments may further operatively communicate with an externalcommand device, such as the mobile device 215, which may provideadditional functionality. For example, the external command device maycommunicate with one or more remote servers to obtain updates for theoperating system, application program(s), and/or configurationparameters usable by the compression garment controller 210 to operatethe untethered wearable active compression therapy system 200.

Examples of additional functionality may include updating therapyalgorithms such as, for example, sequenced inflation and deflation ofselected pneumatic chambers to provide a “kneading” effect that promotesthe movement of lymph toward or away from a desired region of the body.In an illustrative example, each inflation cycle may begin withinflation of the central-most chambers, followed by successive inflationof chambers at increasing distance from the center of the garment, whichmay promote the flow of lymph away from the portion of the limb incontact with the center of the compression garment 205. In such afashion, lymph may be directed to or away from a selected location byprogressive inflation and deflation of selected ones of the pneumaticchambers (1:N) 220.

FIG. 3 depicts a flowchart of an exemplary control method of anexemplary compression therapy routine. In FIG. 3, an exemplary method ofcompression therapy 300 is shown. In some embodiments, such as theexemplary one depicted in FIG. 3, a compression garment controller 210may be configured to operate under the direction of a remote mobiledevice 215. The exemplary method 300 is given from the perspective ofthe microprocessor 235 of the compression therapy controller 210. Themethod 300 begins with the microprocessor 235 waiting 305 to receive acontrol signal from the wireless interface module 250. If themicroprocessor 235 doesn't receive a control signal from the wirelessinterface module 250, the microprocessor 235 continues to wait at step305. If, however, the microprocessor receives a control signal, then themicroprocessor evaluates 310 the control signal as to whether it isrelated to control of the pneumatic pump 270, the valves 275, or thesensors 225. If the control signal is related to the pneumatic pump 270,the microprocessor 235 evaluates 315 the control signal as to whether itis an instruction to turn on the pump 270 or to turn off the pump 270.If the control signal is evaluated to be a turn-pump-on signal, themicroprocessor 235 sends 320 an on-signal to the pump controller 265.If, however, the control signal is evaluated to be a turn-pump-offsignal, the microprocessor 235 sends 325 an off-signal to the pumpcontroller 265. After sending either an on-signal or an off-signal tothe pump controller 265, the method returns to step 305 and themicroprocessor 235 awaits the next control signal.

If, at step 310, the received control signal is evaluated to be a sensorsignal, the microprocessor 235 receives the signals generated by thesensors 225 and sends 340 the received sensor signals to the wirelessinput/output module 250. After sending the received sensor signals tothe wireless input/output module 250, the method 300 returns to step 305and the microprocessor 235 awaits the next control signal.

If, at step 310, the received control signal is a valve signal, themicroprocessor 235 evaluates 345 whether it is an open-valve command ora close-valve command. If the control signal is evaluated to be avalve-open command, the microprocessor 235 sends 350 an open-commandsignal to a valve controller 280 associated with the command signal. If,however, the control signal is evaluated to be a valve-close command,the microprocessor 235 sends 355 a close-command signal to a valvecontroller 280 associated with the command signal. After sending eitheran open signal or a close signal to a valve controller 280 associatedwith the command signal, the method 300 returns to step 305 and themicroprocessor 235 awaits the next control signal.

FIG. 4 depicts a flowchart of an exemplary method of adaptivelyselecting a therapy session associated with a patient's tissuecondition. In FIG. 4, an exemplary method of adaptively selecting atherapy session 400 is shown. In some embodiments, such as the exemplaryone depicted in FIG. 4, a compression garment controller 210 may beconfigured to operate independently of a remote mobile device 215. Theexemplary method 400 is given from the perspective of the microprocessor235 of the compression therapy controller 210. The method 400 beginswith the microprocessor 235 initializing the clock, Tclk, to zero, 405.The microprocessor 235 then initializes the chamber index, N, to zero,410. Then the microprocessor sends 415 an on signal to the pumpcontroller 265 to turn on the pneumatic pump 270. The microprocessor 235then sends 420 the N valve controllers 280 an open signal (indicated byV(N)=1). Some embodiments may adaptively select a therapy session oradaptively adjust a treatment protocol as a function of a patient'sdisease state. In some implementations, a patient's disease state maycomprise the patient's tissue condition. Various implementations mayadaptively select a therapy session or adjust a treatment protocol as afunction of a patient's disease state, using artificial-intelligencetechniques for adaptive treatment adjustment such as those disclosedwith reference to FIGS. 2 and 3 of U.S. application Ser. No. 14/936,462,titled “Dynamically Controlled Treatment Protocols in Close LoopAutonomous Treatment Systems”, filed by Ryan Douglas, on Nov. 9, 2015,the entire contents of which are herein incorporated by reference.

The microprocessor 235 then receives a signal, Pmeas(N), from thepressure sensor associated with the current index, N, and compares 425the received signal, Pmeas(N), with a predetermined threshold, Pset(N).If the received signal, Pmeas(N) is greater than the predeterminedthreshold, Pset(N), then the microprocessor sends 430 an off signal tothe valve controller 280 associated with the current index, N. Theprocessor 235 then assigns 435 the inflation time, Tinf(N), associatedwith the current index, N, to be that of the elapsed clock time, Tclk.Then, or if at step 425, the received signal, Pmeas(N) is not greaterthan the predetermined threshold, Pset(N), then the microprocessor 235evaluates 440 if all the valves are closed. If at least one of thevalves is still open, the current index, N, is incremented 445 by one(or if N is at Nmax, then N is again initialized to zero. Themicroprocessor 235 then returns to step 425 and receives a signal,Pmeas(N), from the pressure sensor associated with the current index, N,and compares the received signal, Pmeas(N), with a predeterminedthreshold, Pset(N).

If, however, at step 440, all of the microprocessor 235 has evaluatedthat all of the valves are closed, the microprocessor 235 determines 450the average inflation time of the chambers. Then the microprocessor 235retrieves 455 a compression therapy schedule associated with thedetermined average inflation time. The high value of the averageinflation time may correspond to a limb that has a relatively smallvolume, for example. A low value of the average inflation time maycorrespond to a limb that has a relatively large volume, for example.The relative small volume limb may indicate that only a small amount offluid retention remains in the limb, for example. A less intensivetherapy schedule may correspond to a small volume limb, whereas a moreintensive therapy schedule may correspond to a large volume limb. Themicroprocessor 235 may then execute 460 the retrieved therapy schedule.

In some embodiments the controller may be configured to operateindependent of a mobile device. For example, in various designs thecontroller may be pre-programmed with a range of appropriate therapiesfor a patient, according to a patient's personalized treatment profile.In some designs, a patient's personalized treatment profile may bedetermined as a function of one or more of: the patient's disease state,standards of care, a physician's prescription, intervention by acaregiver, or global population data. In some implementations, thecontroller may be configured to apply treatment and measure outcome,without a mobile device. In further embodiments, the controller mayarchive treatment compliance data for later upload to a central serveror database. In some embodiments, a user control on an exemplarywearable device may permit a user to operate the controller directly,with or without a mobile device or connection to a central server ordatabase. In various designs, the wearable device may download a therapyrecipe to the controller, which then runs the recipe without connectionto the mobile device.

FIG. 5 depicts a schematic view of an exemplary detachable controllersystem for a wearable inflatable compression therapy garment. Withreference to FIG. 5, a detachable controller 500 for a wearableinflatable compression therapy garment 110 may include a communicationdisplay device 505 communicatively coupled with pluggable controllermodule 510 for operative control of the compression therapy garment. Insome embodiments, the pluggable controller module 510 mayinterchangeably interface via pluggable interface 515 with compressiontherapy garment 110 to operate the compression therapy garment. Invarious implementations, the communication display device may be asmartphone. In various implementations, the pluggable controller may bewirelessly coupled to a smartphone. In some embodiments the pluggableinterface 515 may include glue logic or signal conditioning circuits toadapt the detachable controller to the electrical characteristics ofvarious compression therapy garment electrical interfaces. In someimplementations, power and ground may be provided by the smartphone. Inother implementations, power and ground may be provided by a powersource either integrally formed or releasably coupled to the compressiontherapy garment 110.

In various implementations, the pluggable interface 515 may interconnectthe detachable controller to each of the sensors 225, each of the pumps270, and each of the valves 275 for dynamic control of compressiontherapy in response to control input from the detachable controller orfrom a remote device. In some designs, a physician workstation 130 maycontrol the compression therapy or interact with the patient from aremote location. In further designs the pluggable controller module 510or a smartphone may download therapy protocols from the remote datawarehouse 125. In further embodiments, the pluggable controller module510 or smartphone may upload patient response (e.g., biosense) data ormeasurements of treatment outcomes to the remote data warehouse 125. Inother designs, the pluggable controller may provide status, which mayinclude the result of treatment, to a physician or other user via thecommunication display device. In other embodiments, sensors, pumps, andvalves may be operably interconnected via the pluggable interface to thepluggable controller by a communication and control network 520.

In some designs, the communication and control network between thepluggable interface 515 and the peripheral devices (e.g., pumps, valves,sensors) may be arranged in, for example, a serial (e.g., two wire bus)communication bus, or a star network. In further embodiments, thecommunication and control network may include discrete electricalconnections to all devices throughout the inflatable compression therapygarment, with all connections arriving separately from all points of thegarment. In other designs, the communication and control network may bea buss connected to all devices in parallel, with a logical addressingof the target device. In some designs, the pluggable controller mayinclude a processor, memory, a communication interface, andprocessor-executable program instructions directing the pluggablecontroller to communicate with a smartphone for operative control andmonitoring of compression therapy by a smartphone application.

In some embodiments, the detachable pluggable controller 510 may becontrolled by a smartphone. In other embodiments, the detachablepluggable controller 510 may be a mobile device (e.g., a smartphone),with the smartphone adapted to execute an application program (APP) andprovide an interface to the compression therapy garment 110. In furtherembodiments, the smartphone may be adapted to plug into, or dock with,the compression therapy garment 110 directly and without a separatedetachable pluggable controller 510. In such examples, the smartphonemay directly control the garment, as well as provide bi-directionalcommunication links, via a wide area network (e.g., the Internet), tothird parties, such as the physician workstation 130, the remote datawarehouse 125, and the device manufacturer (who may provide updates toimprove performance or enable access to advanced features or therapeuticprofiles, algorithms, and the calibration, for example).

As depicted, the compression therapy garment 110 includes a pocket 525to removably retain the pluggable controller module 510. In variousimplementations, the compression therapy garment 110 may includemultiple inflatable chambers 530. In other implementations, eachinflatable chamber 530 of a compression therapy garment 110 may beindividually configured with pumps, valves, or sensors independentlyservicing each of the inflatable chambers 530, and providing unique andindependent control and monitoring of each inflatable chamber 530.

Although various embodiments have been described with reference to theFigures, other embodiments are possible. For example, some embodimentsmay have other sensors. For example, a temperature sensor may beincluded in the compression garment. The temperature sensor may be usedto evaluate a person's body temperature and/or the garment temperature.If the garment temperature exceeds a predetermined threshold, thecontroller may evacuate the chambers and re-inflate the chambers withcooler air, for example. In some embodiments, the controller may receivea user temperature setting against which the garment temperature iscompared.

In some implementations, a compression therapy garment may include oneor more integral pumps to inflate one or more inflatable chambersembedded in the garment. In some examples, one or more small weep holesmay vent or release pressure from an inflatable chamber, for example, toambient atmosphere, or to another chamber. In some implementations, thepump may be controllable, alone or in combination with one or morevalves, to provide an adjustable flow rate to a selected chamber.

Various embodiments may have various environmental sensors. For example,some embodiments may include an ambient temperature sensor. In anexemplary embodiment, a barometric pressure sensor may provide anambient pressure signal to an active compression therapy system. Theactive compression therapy system may adjust an intensity of therapybased upon an ambient pressure, for example. In an exemplary embodiment,the inflation pressure may be increased when the ambient pressure islow, for example. Such increased pneumatic pressure may help compensatefor low ambient pressures. In some embodiments the control of pneumaticpressure may assist in normalizing a treatment regime, as uncontrolledparameters affecting the treatment may vary.

In some embodiments, the controller may be affixed to the compressiongarment. In some embodiments, the user may be pneumatically coupled tothe compression garment via one or more air conducting tubes. In someembodiments the controller may be electrically coupled to a compressiongarment that has one or more electrical device attached. By way ofexample and not limitation, a suitable pneumatic pump is commerciallyavailable from Nextern, Inc. of St. Paul, Minn.

In some embodiments more than one pump may be coupled to anactive-compression therapy garment. For example, in some embodiments,each chamber may have a dedicated pump associated with that chamber. Invarious embodiments, each pump may be pneumatically coupled to two,three, four, five, or any reasonable number of chambers in a garment. Insome embodiments, a pump pneumatically coupled to small chambers may becoupled to more chambers than a pump pneumatically coupled to largerchambers. For example, in an exemplary embodiment, a first pneumaticpump is pneumatically coupled to five chambers, and a second pneumaticpump is pneumatically coupled to three chambers whose total volume isgreater than the total volume of the five chambers pneumatically coupledto the first pneumatic pump. In some embodiments, the pumps may becoupled to chambers in a way that causes the chambers to inflate in asequenced fashion. For example, a pump may be pneumatically coupled to afirst of a set of series coupled chambers. The first of the seriescoupled chambers may inflate before the second, and so forth. In someembodiments inflation rates may be controlled by tube diameters, forexample.

In some embodiments the compression garment may be a customizedcompression garment designed to substantially encase a particular bodypart. Exemplary devices with a compression garment designed to treat aparticular body part may deliver optimized therapy specific to the bodypart. For example, in various implementations, the compression garmentmay be customized to substantially encase a foot, for use in compressiontherapy to treat a sprained ankle. In some embodiments, the compressiongarment may be designed to substantially encase a lower leg, below theknee, for compression therapy to treat phlebitis. In variousimplementations, the compression garment may comprise a garment fittedto be worn about at least a portion of the patient's leg, the portion ofa patient's leg substantially encased above or below the knee. In someembodiments, the compression garment may be designed to substantiallyencase a patient's knee. In various implementations, the compressiongarment may be designed to substantially encase a patient's elbow. Infurther implementations, the compression garment may be customized tosubstantially encase a variety of body parts, including: thigh, calf,whole leg, forearm, upper arm, whole arm, hand, wrist, elbow, shoulder,chest, torso, whole head, neck, throat, skull cap, face, or whole body.In some embodiments the compression garment may be configured in theform of: pants, a hat, a glove, a wristband, a sock or stocking, a belt,a shoe, a boot, a coat, a collar, or a cuff. In various designs aparticular compression garment may be adjustable or configurable toadapt to a variety of body parts or a variety of users. Exemplarydevices may be configured with adjustments such as straps, buckles, orfasteners, to adapt a compression garment to the size of a body part. Invarious implementations, the compression garment may be adjusted to fitan adult's larger thigh, by adapting the fit of the compression garmentusing the buckles, straps, or fasteners, and in a similar manner, thecompression garment may be adjusted to adapt the compression garment tofit a child's forearm. In some embodiments, the compression garment mayhave a plurality of inflatable chambers disposed to selectively applycompression therapy to particular regions of the patient's body part.Exemplary devices may have inflatable chambers substantially disposedalong one surface or region of the compression garment. For example, acompression garment designed to treat the patient's migraine headachemay be configured to fit over the patient's head and provide compressionto the skull, including the sides of the head and the forehead. In someembodiments, the compression garment designed to treat the patient'smigraine headache may have a plurality of inflatable chambers disposedin the regions engaging the skull, including the sides of the head andthe forehead. In various implementations, the compression garment may bedesigned with inflatable chambers disposed in the region of thepatient's face, to apply compression therapy to the sinus area, buthaving no inflatable chambers in the rear of the skull.

Various implementations may comprise a plurality of compressiongarments. In some embodiments, more than one compression garment may becontrolled to provide compression therapy to a patient. For example, thecontroller may provide compression therapy by using a leg compressiongarment and an arm compression garment at the same time. In somedesigns, the total force applied to a patient's body by multiplecompression garments may be monitored and constrained to a predeterminedthreshold. In various embodiments, the total force applied to apatient's body may be constrained as a function of the patient's bloodpressure, temperature, respiration rate, or heart rate. In some designs,inflatable chambers may be pressurized with air that is warmer or colderthan ambient temperature. Exemplary devices may combine compressiontherapy with heat or cold therapy. For example, a compression garmentdesigned to treat a patient's migraine headache, or a compressiongarment designed to treat sinus pressure, may be configured with one ormore inflatable chamber and associated pneumatic engine adapted todeliver heat or cold therapy in addition to compression therapy.Exemplary devices may deliver heat or cold therapy within predeterminedtreatment temperature thresholds, in combination with compressiontherapy.

In an exemplary embodiment, a garment connected controller may beconfigured to operate a therapy regime autonomously from a mobiledevice. For example, the garment coupled controller may be incommunication with the mobile device before a therapy schedule isperformed. During this communication, a user may, for example, select aspecific therapy schedule. The mobile device may then transmit a programthat the controller will execute that effects the selected therapyschedule. The controller may then autonomously execute the receivedprogram and obtain periodic sensor data during the therapy schedule. Thecontroller may then upload the sensor data at any convenient time. Forexample, the controller may upload the sensor data when the mobiledevice requests such data. This request may be issued during theexecution of the therapy program or at a later time.

In some embodiments, a garment connected controller may be configured tooperate under the direction of a mobile device. In some embodiments, themobile device may wireless communicate with the controller. In someembodiments, the mobile device may communicate with the controller overa wired connection. In an exemplary embodiment, the controller mayperform low level operations such as started and stopping one or morepneumatic pumps, opening and closing one or more air valves, andtransmitting sensor signals to the mobile device. In some embodiments,higher level operations, such as timing events, coordinating operations,or data analysis, for example, may be performed by the mobile device.Such a low-level only capable controller may advantageously be low-cost,for example.

In some embodiments one or more types of data may be collected regardinga therapy session. For example, some embodiments may collect variousforms of objective data. For example, health data and/or device data maybe collected during a therapy session. By way of example and notlimitation, health data may include, for example, limb density, bodytemperature, heart rate, blood pressure, blood flow. Blood pressure maybe sensed, for example to ensure that the active compression device doesnot inadvertently act as a tourniquet on the limb of the patient. By wayof example and not limitation, device data may include chamber pressure,garment temperature, garment movement, or garment location. For example,garment temperature may be monitored so as to ensure patient comfort. Ifthe garment temperature becomes elevated, the pumps may replace thechambers with fresh cool air, for example. In some embodiments, dataanalysis may be performed on the mobile device.

Subjective data may be collected by querying the patient via a userinterface, for example. In some embodiments, the controller may have auser interface for such a query. In an exemplary embodiment the userinterface of the mobile device may be used to query the patient. By wayof example and not limitation, questions such as: “are youcomfortable?”; “is the temperature acceptable?”; or, “is the pressurenot excessive?” may be asked of the patient. The patient may thenrespond to these and other questions. The objective and/or subjectivedata may then be used to dynamically adjust a therapy routine, in someembodiments. In some embodiments the objective and/or subjective datamay be logged for review by the patient and/or a third party.

In some embodiments a patient may create an accessible database. Forexample, a database may be created online for access by the patientand/or third partied. For example, a child of an elderly patient may begranted access to the patient's database. The child may access thedatabase so as to supervise the elderly patient's therapy, for example.A physician may be granted access to the database to monitor the healthof the patient. In some embodiments the manufacturer may be grantedaccess to the database so as to make intelligent product improvements.Health organizations may be granted access to the patient's data so asto be able to assess specific health concerns affecting the population.

Some aspects of embodiments may be implemented as a computer system. Forexample, various implementations may include digital and/or analogcircuitry, computer hardware, other sensors (e.g. temperature sensors),firmware, software, or combinations thereof. Apparatus elements can beimplemented in a computer program product tangibly embodied in aninformation carrier, e.g., in a machine-readable storage device, forexecution by a programmable processor; and methods can be performed by aprogrammable processor executing a program of instructions to performfunctions of various embodiments by operating on input data andgenerating an output. Some embodiments can be implemented advantageouslyin one or more computer programs that are executable on a programmablesystem including at least one programmable processor coupled to receivedata and instructions from, and to transmit data and instructions to, adata storage system, at least one input device, and/or at least oneoutput device. A computer program is a set of instructions that can beused, directly or indirectly, in a computer to perform a certainactivity or bring about a certain result. A computer program can bewritten in any form of programming language, including compiled orinterpreted languages, and it can be deployed in any form, including asa stand-alone program or as a module, component, subroutine, or otherunit suitable for use in a computing environment.

Suitable processors for the execution of a program of instructionsinclude, by way of example and not limitation, both general and specialpurpose microprocessors, which may include a single processor or one ofmultiple processors of any kind of computer. Generally, a processor willreceive instructions and data from a read-only memory or a random accessmemory or both. The essential elements of a computer are a processor forexecuting instructions and one or more memories for storing instructionsand data. Storage devices suitable for tangibly embodying computerprogram instructions and data include all forms of non-volatile memory,including, by way of example, semiconductor memory devices, such asEPROM, EEPROM, and flash memory devices; magnetic disks, such asinternal hard disks and removable disks; magneto-optical disks; and,CD-ROM and DVD-ROM disks. The processor and the memory can besupplemented by, or incorporated in, ASICs (application-specificintegrated circuits). In some embodiments, the processor and the membercan be supplemented by, or incorporated in hardware programmabledevices, such as FPGAs, for example.

In some implementations, each system may be programmed with the same orsimilar information and/or initialized with substantially identicalinformation stored in volatile and/or non-volatile memory. For example,one data interface may be configured to perform auto configuration, autodownload, and/or auto update functions when coupled to an appropriatehost device, such as a desktop computer or a server.

In some implementations, one or more user-interface features may becustom configured to perform specific functions. An exemplary embodimentmay be implemented in a computer system that includes a graphical userinterface and/or an Internet browser. To provide for interaction with auser, some implementations may be implemented on a computer having adisplay device, such as an LCD (liquid crystal display) monitor fordisplaying information to the user, a keyboard, and a pointing device,such as a mouse or a trackball by which the user can provide input tothe computer. For example, wearable devices, such as Google Glass orother technologies may facilitate input and/or output operations betweena user and a system.

In various implementations, the system may communicate using suitablecommunication methods, equipment, and techniques. For example, thesystem may communicate with compatible devices (e.g., devices capable oftransferring data to and/or from the system) using point-to-pointcommunication in which a message is transported directly from the sourceto the receiver over a dedicated physical link (e.g., fiber optic link,point-to-point wiring, daisy-chain). The components of the system mayexchange information by any form or medium of analog or digital datacommunication, including packet-based messages on a communicationnetwork. Examples of communication networks include, e.g., a LAN (localarea network), a WAN (wide area network), MAN (metropolitan areanetwork), wireless and/or optical networks, and the computers andnetworks forming the Internet. Other implementations may transportmessages by broadcasting to all or substantially all devices that arecoupled together by a communication network, for example, by usingomni-directional radio frequency (RF) signals. Still otherimplementations may transport messages characterized by highdirectivity, such as RF signals transmitted using directional (i.e.,narrow beam) antennas or infrared signals that may optionally be usedwith focusing optics. Still other implementations are possible usingappropriate interfaces and protocols such as, by way of example and notintended to be limiting, USB 2.0, Firewire, ATA/IDE, RS-232, RS-422,RS-485, 802.11 a/b/g/n, Wi-Fi, Ethernet, IrDA, FDDI (fiber distributeddata interface), token-ring networks, or multiplexing techniques basedon frequency, time, or code division. Some implementations mayoptionally incorporate features such as error checking and correction(ECC) for data integrity, or security measures, such as encryption(e.g., WEP) and password protection.

A number of implementations have been described. Nevertheless, it willbe understood that various modification may be made. For example,advantageous results may be achieved if the steps of the disclosedtechniques were performed in a different sequence, or if components ofthe disclosed systems were combined in a different manner, or if thecomponents were supplemented with other components. Accordingly, otherimplementations are contemplated. In addition to the embodimentsexplicitly or implicitly described herein, other implementations arecontemplated within the scope of the following claims.

1-20. (canceled)
 21. A wearable compression therapy apparatus,comprising: a compression garment configured to be worn by a patientwhile providing compression therapy to the patient, the garmentcomprising: at least one selectively controllable actuator operativelycoupled and integrated within the compression garment to provideselective modulation of at least one compression chamber controllablyrelaxed and restricted around at least one body portion in response toactuator control signals, wherein the selective modulation comprises atleast one of: relaxation of the at least one compression chamber, andrestriction of the at least one compression chamber; and, an electricalinterface: (1) operably coupled to the at least one actuator, and (2)integrally attached to the compression garment; and, a compressiongarment controller, affixed to the compression garment, the compressiongarment controller configured to operatively connect directly to theelectrical interface, and configured to generate the actuator controlsignals to send to control a level of the selective modulation of eachof the at least one compression chamber according to a predeterminedcompression therapy profile via the electrical interface, wherein thecompression garment controller is non-pneumatically coupled to the atleast one actuator, wherein the garment is configured to deliver to thepatient the compression therapy according to the predeterminedcompression therapy profile while the patient is ambulatory andphysically untethered to any other devices.
 22. The apparatus of claim21, wherein the at least one compression chamber comprises a pluralityof individual compression segments.
 23. The apparatus of claim 22,wherein each of the plurality of individual compression segments isindependently controllable by the compression therapy controller. 24.The apparatus of claim 22, wherein the compression garment controller isconfigured to sequentially activate at least one set of the plurality ofindividual compression segments in response to the predeterminedcompression therapy profile.
 25. The apparatus of claim 21, wherein: theat least one compression chamber comprises a selectively inflatablepressure chamber, and the selective modulation comprises at least oneof: inflation, and deflation.
 26. The apparatus of claim 24, wherein:the at least one actuator comprises at least one pump and one or morevalves, and the actuator control signals comprise pump control signalsand valve control signals.
 27. The apparatus of claim 21, wherein thecompression garment controller is integrated into the compressiongarment.
 28. The apparatus of claim 21, wherein the compression garmentcontroller comprises a mobile telecommunications device that isphysically unconnected to the compression garment when the compressiongarment is released from the electrical interface.
 29. The apparatus ofclaim 28, wherein the mobile telecommunications device is in datacommunication with the compression garment controller and operable toestablish a communication link with a remote server to receive, from theremote server, information to define the predetermined compressiontherapy profile, and to communicate the received information to thecompression garment controller that is configured to generate theactuator control signals to control the level of selective modulation ofeach of the at least one compression chamber according to thepredetermined compression therapy profile.
 30. The apparatus of claim28, wherein the compression garment controller is in wirelesscommunication with the mobile telecommunications device.
 31. Theapparatus of claim 21, wherein the electrical interface is pluggable andconfigured to releasably attach to the compression garment controller.32. The apparatus of claim 21, further comprising a portable energystorage device attachable to the compression garment to supply operatingpower to perform the predetermined compression therapy.
 33. Theapparatus of claim 21, wherein the compression garment comprises agarment fitted to be worn about at least a portion of a foot of thepatient.
 34. The apparatus of claim 21, wherein the compression garmentcomprises a garment fitted to be worn about at least a portion of a legof the patient.
 35. The apparatus of claim 21, wherein the compressiongarment comprises a garment fitted to be worn about at least a portionof an arm of the patient.
 36. The apparatus of claim 21, wherein thecompression garment comprises a garment fitted to be worn about at leasta portion of a neck of the patient.
 37. The apparatus of claim 21,wherein the compression garment comprises a garment fitted to be wornabout at least a portion of a head of the patient.
 38. The apparatus ofclaim 21, wherein the compression garment comprises a garment fitted tobe worn about at least a portion of a torso of the patient.
 39. Theapparatus of claim 21, wherein the compression garment further comprisesa pocket for storing the compression garment controller.
 40. Theapparatus of claim 21, wherein the compression garment controllercomprises: a processor; and, a program memory tangibly embodied in amachine-readable storage device, the program memory storing instructionsthat, when executed by the processor, cause the processor to performoperations to adjust the predetermined compression therapy profile as afunction of a disease state of the patient by executing at least oneartificial-intelligence technique for adaptive treatment adjustment. 41.A wearable compression therapy apparatus comprising: a compressiongarment configured to be worn by a patient while providing compressiontherapy to the patient, the garment comprising: at least one selectivelycontrollable actuator integrally coupled within the compression garmentto provide at least one of relaxation and restriction of at least onecompression chamber controllably relaxed and restricted around at leastone body portion in response to actuator control signals; an electricalinterface: (1) operably coupled to the at least one actuator, and (2)integrally attached within the compression garment; and, means forreceiving from a remote server information to define a predeterminedcompression therapy profile; and, means for generating the actuatorcontrol signals to send to the at least one actuator to control a levelof relaxation and restriction of each of the at least one compressionchamber according to the predetermined compression therapy profile viathe electrical interface, wherein the means for generating the actuatorcontrol signals is affixed to the compression garment and configured tooperatively connect directly to the electrical interface, and, whereinthe means for generating the actuator control signals isnon-pneumatically coupled to the at least one actuator.